Hand Jing-Well Points Stimulation to Treat Disorders of Consciousness (Wells-DoC)

June 8, 2026 updated by: Xijing Hospital

A Multi-center Randomised Controlled Trial to Explore the Ideal Stimulation Strategies at Hand Twelve Jing-Well Points in Patients With Disorders of Consciousness

The purpose of this academic lead study is to explore the ideal stimulation strategies at Hand twelve jing-well points in patients with disorders of consciousness.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital
      • Xi'an, Shaanxi, China, 710068
        • Shaanxi Provincial People's Hospital
      • Xi'an, Shaanxi, China, 710038
        • Xi'an TCM Hospital of Encephalopathy
      • Xi'an, Shaanxi, China, 710100
        • Xi'an International Medical Center Hospita

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age: 18-80 years old
  • From 7 to 90 days since brain injury
  • Diagnosed in VS/UWS or MCS as defined by at least two CRS-R assessments performed during the screening period
  • Acquired cerebral damage of known etiology
  • Intact hand skin
  • Informed consent given by the legal surrogate

Exclusion Criteria:

  • Patients who continuously receive sedative drugs and Na+ or Ca2+ channel blockers (e.g., carbamazepine) or NMDA receptor antagonists (e.g., dextromethorphan)
  • History of previous serious、progressive neurological disorder prior to the brian injury
  • Epilepsy and seizure
  • Unstable vital signs or life-threatening comorbidities
  • Active implant (e.g., cardiac pacemakers/defibrillators, deep brain stimulators, ventriculoperitoneal shunt, etc)
  • Documented pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bloodletting Puncture
Bloodletting puncture at hand twelve jing-well points for 5 consecutive days, once a day, combined with conventional medical treatment.
Other: Bloodletting Acupuncture
Bloodletting was applied to the right hand first and then the left hand in the order of Shaoshang (LU 11), Shangyang (LI 1), Zhongchong (PC 9), Guanchong (TE 1), Shaochong (HT 9) and Shaoze (SI 1).
Experimental: Transcutaneous electrical stimulation
Transcutaneous electrical acupoint stimulation at hand twelve jing-well points for 5 consecutive days, once a day, combined with conventional medical treatment.
Device: Transcutaneous electrical stimulation
Transcutaneous electrical acupoint stimulation at hand twelve jing-well points.
No Intervention: Control
Control group was treated with conventional medical treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coma Recovery Scale-Revised (CRS-R) change
Time Frame: baseline, immediately after the end of the 5-day treatment
CRS-R score ranges from 0 to 23, with higher scores mean a better outcome.
baseline, immediately after the end of the 5-day treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ABCD model change
Time Frame: baseline, immediately after the end of the 5-day treatment
This model classifies the power spectrum of resting-state EEG data into four categories: A, B, C, and D. Type A exhibits a power spectrum peak in the delta range (0-4 Hz), indicative of a completely disconnected thalamocortical network. Type B shows a primary power spectrum peak in the theta range (4-8 Hz), reflecting a severely disconnected thalamocortical network. Type C exhibits power spectrum peaks in both the theta (4-8 Hz) and beta (13-24 Hz) ranges, indicative of a moderately disconnected thalamocortical network. Type D shows power spectrum peaks in the alpha (8-13 Hz) and beta ranges, representing a fully intact thalamocortical network.
baseline, immediately after the end of the 5-day treatment
ABCD model change
Time Frame: baseline, immediately after the end of the first treatment
This model classifies the power spectrum of resting-state EEG data into four categories: A, B, C, and D. Type A exhibits a power spectrum peak in the delta range (0-4 Hz), indicative of a completely disconnected thalamocortical network. Type B shows a primary power spectrum peak in the theta range (4-8 Hz), reflecting a severely disconnected thalamocortical network. Type C exhibits power spectrum peaks in both the theta (4-8 Hz) and beta (13-24 Hz) ranges, indicative of a moderately disconnected thalamocortical network. Type D shows power spectrum peaks in the alpha (8-13 Hz) and beta ranges, representing a fully intact thalamocortical network.
baseline, immediately after the end of the first treatment
Coma Recovery Scale-Revised (CRS-R) change
Time Frame: baseline, immediately after the end of the first treatment
CRS-R score ranges from 0 to 23, with higher scores mean a better outcome.
baseline, immediately after the end of the first treatment
Incidence of Adverse Events
Time Frame: from the first treatment to the end of the fifth treatment
The incidence of adverse events occurred during the intervention period, including treatment intolerance：painful facial expressions, moans, crying, and head movements；Local adverse effect：skin infections (redness, swelling, suppuration), subcutaneous ecchymosis, skin burns (blisters or eschar formation)；Systemic adverse effect：epileptic seizures。
from the first treatment to the end of the fifth treatment
Glasgow Outcome Scale-Extended (GOSE)
Time Frame: at six months post enrollment
A GOSE score of 1 indicates death, 2 indicates a vegetative state, 3 to 4 indicates severe disability, 5 to 6 indicates moderate disability, and 7 to 8 indicates good recovery. Favorable functional outcome is defined as an GOSE score of 4-8, while unfavorable functional outcome is defined as an GOSE score of 1-3.
at six months post enrollment
Consciousness level change
Time Frame: baseline, at six months post enrollment
The level of consciousness was evaluated using CRS-R score. Patients who transitioned from UWS to MCS (UWS-MCS) or to emergence from MCS (EMCS) (UWS-EMCS), from MCS minus to MCS plus (MCS - -MCS + ) or to EMCS (MCS - -EMCS), and from MCS to EMCS (MCS-EMCS) were categorized in the improved consciousness group. The unimproved consciousness was defined as a reduced or unchanged level of consciousness.
baseline, at six months post enrollment
Correlation between EEG responsiveness and long-term outcomes
Time Frame: on the first day, the fifth day and at six months post enrollment
EEG responsiveness to the treatment was considered positive if, after the hand Jing-Well points stimulation, patients exhibited elevated levels of EEG "ABCD" patterns compared to the baseline after either the first or fifth stimulation session. The correlation between EEG responsiveness and long-term consciousness improvement and favorable functional outcome was assessed.
on the first day, the fifth day and at six months post enrollment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coma Recovery Scale-Revised (CRS-R)
Time Frame: Immediately after the first treatment
CRS-R score ranges from 0 to 23, with higher scores mean a better outcome.
Immediately after the first treatment
ABCD model
Time Frame: Immediately after the first treatment
This model classifies the power spectrum of resting-state EEG data into four categories: A, B, C, and D. Type A exhibits a power spectrum peak in the delta range (0-4 Hz), indicative of a completely disconnected thalamocortical network. Type B shows a primary power spectrum peak in the theta range (4-8 Hz), reflecting a severely disconnected thalamocortical network. Type C exhibits power spectrum peaks in both the theta (4-8 Hz) and beta (13-24 Hz) ranges, indicative of a moderately disconnected thalamocortical network. Type D shows power spectrum peaks in the alpha (8-13 Hz) and beta ranges, representing a fully intact thalamocortical network.
Immediately after the first treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2025

Primary Completion (Actual)

December 26, 2025

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

March 30, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 15, 2025

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20252094JIANGWEN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data are available in the main text.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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